Following a vote in September, the US Food and Drug Administration (FDA) approved on Friday, Palforzia, the first drug meant to treat peanut allergies in children ages four to 17, with the goal of limiting allergic reactions (including anaphylaxis) that can occur from accidental exposure.
“Peanut allergy affects approximately one million children in the U.S. and only one out of five of these children will outgrow their allergy. Because there is no cure, allergic individuals must strictly avoid exposure to prevent severe and potentially life-threatening reactions,” said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement for the FDA. “Even with strict avoidance, inadvertent exposures can and do occur. When used in conjunction with peanut avoidance, Palforzia provides an FDA-approved treatment option to help reduce the risk of these allergic reactions in children with peanut allergy.”
A peanut allergy occurs when a body’s immune system accidentally registers whatever amount of peanut (no matter how small) it’s been exposed to as harmful, according to the FDA. The symptoms can develop almost immediately following exposure and can include hives, redness, swelling, digestive problems or constriction in the throat, airways or blood flow. And these allergies are common — a 2017 study found that the rate of peanut allergies in children has increased 21 percent since 2010.
The treatment via Palforzia, an allergen powder manufactured from peanuts, works in three phases, according to the FDA: There’s the initial dose (given in one day) and 11 increasing up-doses over several months that are administered with healthcare provider supervision. The powder, which is packaged in pull-apart capsules can be mixed in with semisolid foods like applesauce, yogurt or pudding. After the Up-Dosing, patients begin their “daily maintenance dose,” provided they don’t have reactions that need them to discontinue treatment or alter the dosing schedule.
The drug was studied in the U.S., Canada and Europe in a randomized, double-blind, placebo-controlled study with 500 peanut-allergic subjects. Researchers found that 67.3 percent of the patients were able to handle a 600 mg dose of peanut protein after six months of maintenance treatment (compared to four percent of the placebo patients). While it’s not a cure for peanut allergies and doesn’t mean that kids with allergies are no longer at risk, it does mean that a small accidental exposure can be less impactful and less dangerous.
“While anaphylaxis can occur at any time during Palforzia therapy, patients are at highest risk during and after the Initial Dose Escalation and the first dose of each Up-Dosing level,” the FDA’s press release said. “During Up-Dosing, if the patient tolerates the first dose of an increased dose level, the patient may continue that dose level daily at home.”
To reduce the risk of anaphylaxis from exposure to the drug, the FDA is requiring medical professionals to incorporate a Risk Evaluation and Mitigation Strategy (REMS) with requirements for safe use that include additional education on anaphylaxis risks and symptoms for providers of the treatment and additional monitoring for patients during the first two dosing steps.
Source: Read Full Article